In Part 2, Amir Kalali, MD, Independent Consultant, continues the discussion with Luca Pani, MD, focusing on how AI could fundamentally transform CNS drug development by enabling deeper biological insight, patient enrichment, and real-world outcome assessment, while emphasizing the cultural resistance, regulatory transparency, ethical trust, and leadership readiness required for responsible adoption.

In Part 1, Gary Sachs, MD, Clinical Vice President at Signant Health, moderates a discussion with Luca Pani, MD, President of ISCTM and Chief Regulatory and Innovation Officer at NetraMark. The conversation examines how AI can be used to support drug development, clinical trial design, and data interpretation, alongside key regulatory, ethical, and scientific considerations.

In this introductory episode of Mind the Methods, host Elizabeth Pappadopulos, PhD, introduces the mission, scope, and audience of the ISCTM podcast. She outlines how the series will explore innovations in CNS clinical trial design and methodology ranging from digital endpoints, adaptive protocols, and generative AI to patient-centric approaches and real-world challenges across psychiatric, neurologic, and neurodegenerative research. Episode 00 sets the stage for thoughtful, expert-led conversations with researchers, clinicians, industry leaders, and regulators, all focused on advancing rigorous methodology and improving outcomes for patients in CNS drug development.